A Study to Investigate the Efficacy and Safety of Eribulin in Korean Breast Cancer Participants

Locally Advanced or Metastatic Breast Cancer Clinical Trial

Official title:

A Nationwide, Multi-institutional Retrospective Study of Efficacy and Safety of Eribulin in Korean Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437083
• Other study ID #: E7389-M082-602
• Status: Completed
• Start date: January 25, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to observe efficacy in terms of progression-free survival rate at 6 months in eribulin-treated breast cancer participants retrospectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of locally advanced or metastatic breast cancer

• Participants who were treated with Eribulin between 01 June, 2014 and 31 December, 2016

Exclusion Criteria:

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced or Metastatic Breast Cancer

Intervention

Drug:
• Eribulin mesylate
intravenous infusion

Locations

Country	Name	City	State
Korea, Republic of	Eisai Trial site_03	Ansan
Korea, Republic of	Eisai Trial site_04	Busan
Korea, Republic of	Eisai Trial site_05	Busan
Korea, Republic of	Eisai Trial site_06	Busan
Korea, Republic of	Eisai Trial site_09	Daegu
Korea, Republic of	Eisai Trial site_13	Daejeon
Korea, Republic of	Eisai Trial site_14	Gwangju
Korea, Republic of	Eisai Trial site_01	Seoul
Korea, Republic of	Eisai Trial site_02	Seoul
Korea, Republic of	Eisai Trial site_07	Seoul
Korea, Republic of	Eisai Trial site_10	Seoul
Korea, Republic of	Eisai Trial site_11	Seoul
Korea, Republic of	Eisai Trial site_12	Seoul
Korea, Republic of	Eisai Trial site_08	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) rate at 6 months	PFS rate at 6 months is estimated based on the tumor response evaluation and is defined as the proportion of participants alive and progression-free at 6 months from the initial treatment of eribulin.	6 months
Secondary	Progression-Free Survival (PFS)	PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up.	From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years)
Secondary	Overall Survival (OS)	OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up.	From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)
Secondary	Time to treatment failure (TTF)	TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.	From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
Secondary	Tumor response rate (TRR)	TRR will be evaluated by medical records. ORR is defined as the sum of obtained PR and CR and the clinical benefit rate (CBR) is defined as the sum of PR, CR and stable disease (SD) maintained for at least six months. Disease control rate (DCR) is defined as the sum of PR, CR and SD.	From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)
Secondary	Number of participants with any treatment-emergent adverse event (TEAE)	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.	6 months
Secondary	PFS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)	PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up.	From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years)
Secondary	OS in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)	OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up.	From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)
Secondary	TTF in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)	TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.	From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
Secondary	TRR in eribulin-treated breast cancer participants according to line of treatment for advanced disease and tumor subtype (receptor status and molecular subtype)	TRR will be evaluated by medical records. ORR is defined as the sum of obtained PR and CR and the CBR is defined as the sum of PR, CR and SD maintained for at least six months. DCR is defined as the sum of PR, CR and SD.	From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)
Secondary	PFS rate in eribulin-treated breast cancer participants comparing early (= third line) to late (= fourth line) use	PFS is defined as the time from the start date of therapy with eribulin to the date of disease progression or death from any cause. Participants without progression will be censored, progression free at the date of late follow-up.	From the start date of therapy with eribulin to the date of disease progression or death from any cause (1 day to up to approximately 2 years)
Secondary	OS in eribulin-treated breast cancer participants comparing early (= third line) to late (= fourth line) use	OS is defined as the time from the start date of therapy with eribulin to the date of death from any cause or last follow-up.	From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)
Secondary	TTF in eribulin-treated breast cancer participants comparing early (= third line) to late (= fourth line) use	TTF is defined as a time from first treatment with eribulin to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.	From the first treatment with eribulin to discontinuation of treatment for any reason (1 day to up to approximately 2 years)
Secondary	TRR in eribulin-treated breast cancer participants comparing early (=third line) to late (= fourth line) use	TRR will be evaluated by medical records. ORR is defined as the sum of obtained (PR) and CR and the CBR is defined as the sum of PR, CR and SD maintained for at least 6 months. DCR is defined as the sum of PR, CR and SD.	From the start date of therapy with eribulin to the date of death from any cause or last follow-up (1 day to up to approximately 2 years)
Secondary	Number of participants with the indicated action to TEAEs	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.	6 months
Secondary	Number of participants with TEAEs resulting in discontinuation of eribulin	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.	6 months
Secondary	Number of participants using supportive drugs to treat AEs	Treatment of adverse events will be collected retrospectively.	6 months
Secondary	Median number of eribulin cycles	Data will be collected to observe a treatment pattern of eribulin in the real world.	6 months
Secondary	Number of participants experiencing a dose reduction	Data will be collected to observe a treatment pattern of eribulin in the real world.	6 months
Secondary	Mean duration of treatment	Duration of treatment is defined as the time from documentation of the start of eribulin treatment to the date of permanent discontinuation.	6 months
Secondary	Mean duration of response	Duration of response is defined as the time from the first documented evidence of CR or PR (whichever status is recorded first) until the first documented sign of disease progression or death due to any cause.	6 months
Secondary	Mean dose intensity	Dose intensity is defined as the amount of drug milligrams per meters squared (mg/m^2) delivered to a participant in a week of treatment.	6 months
Secondary	Number of participants with the indicated reason for treatment discontinuation	Data will be collected to observe a treatment pattern of eribulin in the real world.	6 months